Priority Review Fee definition

Priority Review Fee has the meaning set forth in Section 11.02.
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Priority Review Fee means the fees described in 21 U.S.C. 360bbb-4a(c).
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Priority Review Fee has the meaning given is Section 529(c) of the FFDCA. (jj) “Priority Review Voucher” means the priority review voucher issued by the Secretary of the Department of Health and Human Services pursuant to Section 529(b)(1) of the FFDCA to Seller and assigned tracking number PRV NDA 218709 that entitles the holder of such voucher to Priority Review of a single human drug application submitted under Section 505(b)(1) of the FFDCA or section 351(a) of the PHSA. (kk) “Purchased Assets” means (i) the Priority Review Voucher and (ii) any and all rights, benefits and entitlements with respect thereto afforded to the holder of such Priority Review Voucher. (ll) “Rare Pediatric Disease” means rare pediatric disease as defined in Section 529(a)(3) of the FFDCA. (mm) “Representative” means, with respect to a particular Person, any director, officer, manager, employee, agent, consultant, advisor, accountant, financial advisor, legal counsel, or other representative of that Person. (nn) “SEC” has the meeting set forth in Section 5.3. (oo) “Tax” or “Taxes” means [***]. (pp) “Third Party” means any Person other than a Party and such Party’s Affiliates.
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Examples of Priority Review Fee in a sentence

  • The Priority Review Fee and all other user fees under the FDCA applicable to the human drug application for which the Priority Review Voucher is redeemed, following the Closing, shall be borne exclusively by Buyer, its Affiliates or any transferee of the Priority Review Voucher.

  • In furtherance and not in limitation of the foregoing, Buyer shall timely pay all amounts due with respect to the Priority Review Fee in connection any submission of a Pre-Closing PRV Notice as contemplated by Section 4.1 or other Notice of Intent to Use the Priority Review Voucher by Buyer.

  • The Priority Review Fee is not due by the Lease Applicant if the Lease Request is rejected.

  • Maintenance shall be scheduled to prevent storm water from backing up into the driving lane.

  • The Priority Review Fee and all other user fees under the FDC Act applicable to the human drug application for which the Priority Review Voucher is redeemed shall be borne exclusively by Buyer or any transferee of the Priority Review Voucher.

  • The Priority Review Fee and all other user fees under the FDC Act applicable to the human drug application forwhich the Priority Review Voucher is redeemed shall be borne exclusively by Buyer or any transferee of the Priority Review Voucher.

Related to Priority Review Fee

  • Review Fee has the meaning stated in Section 4.3(b).

  • Trust Reimbursement Amount As defined in Section 3.06A(a) of this Agreement.

  • Priority List means the annual listing of fundable, waiting, and planning portion projects.

  • LPMI Fee With respect to each LPMI Loan, the portion of the Mortgage Interest Rate as set forth on the related Mortgage Loan Schedule (which shall be payable solely from the interest portion of Monthly Payments, Insurance Proceeds, Condemnation Proceeds or Liquidation Proceeds), which, during such period prior to the required cancellation of the LPMI Policy, shall be used to pay the premium due on the related LPMI Policy.

  • Advance Reimbursement Amount has the meaning stated in Section 4.4(b) of the Servicing Supplement.

  • Workout-Delayed Reimbursement Amount As defined in subsection (II)(i) of Section 3.05(a).

  • First Liquidation Target Amount has the meaning assigned to such term in Section 6.1(c)(i)(D).

  • Initiation fee means a fee charged by us to you in order to create a credit facility for you;

  • Liquidation Fee With respect to each Specially Serviced Loan as to which the Special Servicer receives a full or discounted pay-off (or unscheduled partial payment to the extent such prepayment is required by the Special Servicer as a condition to a workout or results from the Special Servicer’s collection and enforcement efforts) from the related Mortgagor, except as otherwise described below, with respect to any Mortgage Loan (or Serviced Whole Loan) repurchased or substituted as contemplated by Section 2.03 of this Agreement and/or any Specially Serviced Loan or any REO Property as to which the Special Servicer receives Liquidation Proceeds, Insurance Proceeds or Condemnation Proceeds, an amount calculated by the application of the applicable Liquidation Fee Rate to the related payment or proceeds (exclusive of any portion of such pay-off or proceeds that represents Penalty Charges); provided that, except as contemplated by the following provisos, no Liquidation Fee will be less than $25,000; provided, further, that the Liquidation Fee (which, if payable, shall, prior to the reduction in accordance with this proviso, be at least $25,000) with respect to any related Specially Serviced Loan or REO Property shall be reduced by the amount of any Excess Modification Fees paid by or on behalf of the related Mortgagor with respect to the Specially Serviced Loan or REO Property as described in the definition of “Excess Modification Fees” in this Agreement, but only to the extent those fees have not previously been deducted from a Workout Fee or Liquidation Fee; provided, further, that (a) the Liquidation Fee shall be zero with respect to any Mortgage Loan or Serviced Whole Loan or any Mortgaged Property purchased or repurchased pursuant to clauses (iii) through (v) of the first sentence of the definition of Liquidation Event (unless with respect to (A) clause (iii), the applicable Mortgage Loan Seller does not repurchase or substitute for such Mortgage Loan until after more than 180 days following its receipt of notice or discovery of a Material Breach or Material Document Defect, and (B) clause (v), the mezzanine loan holder or the Subordinate Companion Loan Holder does not purchase such Mortgage Loan or Serviced Whole Loan within 90 days of when the first purchase option first becomes exercisable under the related intercreditor agreement or Co-Lender Agreement, as applicable) or pursuant to clauses (ii) or (iv) of the second sentence of such definition (unless with respect to clause (iv), the mezzanine loan holder does not purchase such REO Property within 90 days of when the first purchase option first becomes exercisable) and (b) the Liquidation Fee with respect to each Mortgage Loan or REO Mortgage Loan repurchased or substituted for after more than 180 days following the Mortgage Loan Seller’s receipt of notice or discovery of a Material Breach or Material Document Defect shall be in an amount equal to the Liquidation Fee Rate of the outstanding principal balance of such Mortgage Loan or REO Mortgage Loan; provided, further, that if a Mortgage Loan or Serviced Whole Loan becomes a Specially Serviced Loan only because of an event described in clause (a)(ii) of the definition of “Specially Serviced Loan” regarding the related Mortgagor’s failure to make a Balloon Payment and the related Liquidation Proceeds are received within 90 days following the related maturity date in connection with the full and final pay-off of the related Mortgage Loan or Serviced Whole Loan, the Special Servicer will not be entitled to collect a Liquidation Fee, but may collect and retain appropriate fees from the related Mortgagor in connection with such liquidation.

  • Priority Claim means a Claim that is entitled to priority in payment pursuant to section 507(a) of the Bankruptcy Code that is not an Administrative Claim or a Priority Tax Claim.

  • Distribution Fee means a percentage of MRP of each of the Subscribed Channels payable by SDSPL to the Licensee towards fee for distribution of each of the Subscribed Channels as more specifically specified in Annexure B and Annexure B-1 of this Agreement.

  • Priority Tax Claim means any Claim of a Governmental Unit of the kind specified in section 507(a)(8) of the Bankruptcy Code.

  • Servicer Prepayment Charge Payment Amount The amounts payable by the Servicer in respect of any waived Prepayment Charges pursuant to Section 2.05 or Section 3.01.

  • Designated Second Priority Representative means (i) the Initial Second Priority Representative, until such time as the Second Priority Debt Facility under the Initial Second Priority Debt Documents ceases to be the only Second Priority Debt Facility under this Agreement and (ii) thereafter, the Second Priority Representative designated from time to time by the Second Priority Instructing Group, in a notice to the Designated Senior Representative and the Company hereunder, as the “Designated Second Priority Representative” for purposes hereof.

  • Master Servicer Prepayment Charge Payment Amount The amounts payable by the Master Servicer pursuant to Section 2.03(b) in respect of any waived (or, with respect to subsequent changes of law, any unenforceable) Prepayment Charges.

  • Sewage sludge fee weight means the weight of sewage sludge, in dry U.S. tons, excluding admixtures such as liming materials or bulking agents. Annual sewage sludge fees, as per section 3745.11(Y) of the Ohio Revised Code, are based on the reported sludge fee weight for the most recent calendar year.

  • Workout-Delayed Reimbursement Amounts With respect to any Mortgage Loan or Serviced Loan Combination, the amount of any Advance made with respect to such Mortgage Loan or Serviced Loan Combination on or before the date such Mortgage Loan or Serviced Loan Combination becomes (or, but for the making of three monthly payments under its modified terms, would then constitute) a Corrected Loan, together with (to the extent accrued and unpaid) interest on such Advances, to the extent that (i) such Advance is not reimbursed to the Person who made such Advance on or before the date, if any, on which such Mortgage Loan or Serviced Loan Combination becomes a Corrected Loan and (ii) the amount of such Advance becomes a future obligation of the Mortgagor to pay under the terms of modified Loan Documents. That any amount constitutes all or a portion of any Workout-Delayed Reimbursement Amount shall not in any manner limit the right of any Person hereunder to determine in the future that such amount instead constitutes a Nonrecoverable Advance.

  • Priority 1 means a critical full outage/severe issue that constitutes a catastrophic problem that causes complete inability to use the Subscription Service, excluding Free Services, across a significant portion of the production environment (e.g. crash or hang), resulting in production downtime and where there is no workaround or solution to the problem.

  • Penalty Charge Notice means a notice served by a Civil Enforcement Officer pursuant to the provisions of section 78 of the 2004 Act and supporting regulations;

  • Professional Fee Amount means the aggregate amount of Professional Fee Claims and other unpaid fees and expenses that Professionals estimate they have incurred or will incur in rendering services to the Debtors prior to and as of the Confirmation Date, which estimates Professionals shall deliver to the Debtors as set forth in Article II.B of the Plan.

  • Second Priority Principal Distribution Amount means, with respect to any Payment Date, an amount equal to (a) the excess, if any, of (i) the Note Balance as of such Payment Date (before giving effect to any principal payments made on the Class A Notes and the Class B Notes on such Payment Date), over (ii) the Adjusted Pool Balance for such Payment Date minus (b) the First Priority Principal Distribution Amount for such Payment Date; provided, however, that the Second Priority Principal Distribution Amount on the Class B Final Scheduled Payment Date shall not be less than the amount that is necessary to reduce the outstanding principal amount of the Class B Notes to zero.

  • Advance Reimbursement Amounts As defined in Section 3.29 hereof.

  • Servicing Advance Reimbursement Amounts As defined in Section 3.22.

  • Priority Lien Cap means, as of any date, the maximum aggregate principal amount of Indebtedness permitted to be incurred by clause (1) of the definition of Permitted Debt. For purposes of this definition, all letters of credit will be valued at the face amount thereof, whether or not drawn.

  • Additional Fee means a fee, in addition to the licence fee, imposed by the municipality on a business at any time during the term of the licence for costs incurred by the municipality attributable to the activities of the business;

  • Priority Tax Claims means Claims of governmental units of the kind specified in section 507(a)(8) of the Bankruptcy Code.